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Clinical Trial
. 2004 Mar 22;90(6):1156-62.
doi: 10.1038/sj.bjc.6601709.

Safety and efficacy of subcutaneous and continuous intravenous infusion rIL-2 in patients with metastatic renal cell carcinoma

P F Geertsen  1 , M E Gore, S Negrier, J M Tourani, H von der Maase
Affiliations
Clinical Trial

Safety and efficacy of subcutaneous and continuous intravenous infusion rIL-2 in patients with metastatic renal cell carcinoma

P F Geertsen et al. Br J Cancer. .

Abstract

A retrospective analysis was conducted on data from four open-label, nonrandomised, phase II trials of recombinant interleukin-2 (rIL-2) in patients with metastatic renal cell carcinoma to compare the safety and efficacy of administration by subcutaneous (s.c.) and continuous intravenous (c.i.v.) infusion (n=103 s.c. and n=225 c.i.v.). No statistically significant differences were found between the cohorts in terms of overall response rate (s.c.: 13.6% vs c.i.v.: 12.4%, P=0.77), response duration (s.c.: 9.8 months vs c.i.v.: 10.1 months, P=0.99), and overall survival (P=0.08). Compared with c.i.v. administration, more patients in the s.c. cohort experienced stable disease (50.5 vs 29.8%) and fewer underwent disease progression (35.0 vs 43.6%). Subcutaneous administration was associated with a significantly lower incidence of grade 3 or 4 adverse events (46 vs 76%; P<0.001), and fewer s.c. patients required dose reductions because of toxicity (20 vs 82%). At the doses and within the schedules tested, this comparative analysis did not detect any difference in efficacy between s.c. and c.i.v. administration of rIL-2 in terms of overall survival, duration of response and response rate in patients with metastatic renal cell carcinoma. However, s.c. delivery of rIL-2 was associated with improved tolerability.

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Figures

Figure 1
Figure 1
Dosing regimens used in studies analysed in this retrospective analysis (A) Study SC1 (12-week subcutaneous treatment using 4- or 6-week cycles – Protocol NL-MP-100). (B) Study SC2 (subcutaneous treatment until disease progression/unacceptable toxicity – Protocol EC-MP-101). (C) Studies CIV1 and CIV2 (continuous intravenous treatment until disease progression or unacceptable toxicity or up to a maximum of four maintenance cycles – Protocols EC-L2-008 and EC-MP-001).
Figure 2
Figure 2
Overall survival in patients with metastatic renal cell carcinoma treated with subcutaneous (s.c.) or continuously infused (c.i.v.) rIL-2; retrospectively pooled data from open-label, nonrandomised trials.
See this image and copyright information in PMC

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